Virtual Reality's Effect on Decreasing Pain and Subsequent Opioid Use in Pediatric Patients in the Post-Operative Period Following Scoliosis Repair

Sponsor
Northwell Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT05888038
Collaborator
(none)
50
1
1
24.9
2

Study Details

Study Description

Brief Summary

The goal of this study is to determine whether introducing VR in the immediate post-operative period following scoliosis repair can reduce perceived pain and stress in pediatric patients and in turn ultimately decrease opioid use. Based on previous studies that have been performed in other fields of pediatrics showing a decrease in pain and stress with VR use, the investigators hypothesize that VR will significantly decrease patient's reported level of pain and stress immediately following the VR session, and that patients will require less opioids during their inpatient stay as a result.

Condition or Disease Intervention/Treatment Phase
  • Device: virtual reality
N/A

Detailed Description

This project evaluates whether providing pediatric post-operative scoliosis repair patients with a virtual reality (VR) session at specific time point following surgery can decrease pain and stress experienced and if this leads to a decrease in the use of pain medications required during the immediate recovery period. Virtual reality technology was ordered to use as a distraction tool as part of routine pediatric care for hospitalized patients. The study involves measuring pain and stress using validated scales as well as calculating opioid use in this specific pediatric post-operative scoliosis repair population. All post-operative scoliosis repair patients admitted to the inpatient pediatric floor above 7 years of age will be eligible for participation in this study. The goal is to collect data on at least 50 patients over the course of 12-18 months. Parental consent and child assent will be obtained on day 2 post-op surgery using a standardized consent and assent form, respectively. Data will be collected from the Numerical Pain Rating Scale and the State Trait Anxiety Inventory, which will be administered pre- and post-VR sessions, with the goal of comparing scores to evaluate for any decrease in pain and stress levels. Data on inpatient opioid use post-operatively will be used to compare with previous post-operative scoliosis patients to determine whether there a significant decrease in opioid use in the subjects exposed to VR. During the data collection process, results will be documented in an organized but deidentified manner.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Virtual Reality's Effect on Decreasing Pain and Subsequent Opioid Use in Pediatric Patients in the Post-Operative Period Following Scoliosis Repair
Actual Study Start Date :
Sep 3, 2022
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention - use of VR

Device: virtual reality
virtual reality

Outcome Measures

Primary Outcome Measures

  1. Pain Assessment [2 years]

    Use of virtual reality device exercise to reduce perception of pain. Participant will complete Numerical Pain Rating Scale.

  2. Stress Assessment [2 years]

    Participant will complete and the State Trait Anxiety Inventory to assess stress

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • all pediatric patients post scoliosis repair

  • age 7-21

Exclusion Criteria:
  • age less than 7 years;

  • history of seizures, epilepsy,

  • history of motion sickness/balance problems,

  • susceptibility to migraines

  • currently pregnant

Contacts and Locations

Locations

Site City State Country Postal Code
1 SIUH Northwell Health Staten Island New York United States 10305

Sponsors and Collaborators

  • Northwell Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Northwell Health
ClinicalTrials.gov Identifier:
NCT05888038
Other Study ID Numbers:
  • 22-0286
First Posted:
Jun 5, 2023
Last Update Posted:
Jun 5, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 5, 2023